The following data is part of a premarket notification filed by Cook Incorporated with the FDA for Check-flo Performer Introducer Micropuncture Radial Artery Access Set.
| Device ID | K171609 |
| 510k Number | K171609 |
| Device Name: | Check-Flo Performer Introducer Micropuncture Radial Artery Access Set |
| Classification | Introducer, Catheter |
| Applicant | Cook Incorporated 750 Daniels Way Bloomington, IN 47404 |
| Contact | Jennifer Allman |
| Correspondent | Jennifer Allman Cook Incorporated 750 Daniels Way Bloomington, IN 47404 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-06-01 |
| Decision Date | 2018-06-04 |
| Summary: | summary |